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Trial registered on ANZCTR
Registration number
ACTRN12625000131459
Ethics application status
Approved
Date submitted
1/02/2024
Date registered
6/02/2025
Date last updated
6/02/2025
Date data sharing statement initially provided
6/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Does treatment with naltrexone (a medication) improve quality of life in patients with hypothyroidism (underactive thyroid)?
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Scientific title
ThyroLDN: a phase 2, double blind, randomised controlled trial of low dose naltrexone on thyroid-specific quality of life in Hashimoto’s thyroiditis patients with residual hypothyroid symptoms despite optimal thyroid hormone replacement.
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Secondary ID [1]
311444
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None
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Universal Trial Number (UTN)
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Trial acronym
ThyroLDN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypothyroidism
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Hashimoto's disease
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Condition category
Condition code
Metabolic and Endocrine
329468
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0
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Thyroid disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Naltrexone 4.5 mg oral capsule daily for 6-months. Adherence will be assessed by drug tablet return
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Intervention code [1]
327897
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Treatment: Drugs
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Comparator / control treatment
Placebo - size 0 Swedish orange capsule containing microcrystalline cellulose USP/EP capsules
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Change in thyroid specific quality of life
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Assessment method [1]
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ThyPRO-39 survey instrument
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Timepoint [1]
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The primary outcome measure will be change from baseline assessed at 6-months post commencement of treatment. Additional secondary timepoints will include 3 months post commencement of treatment.
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Secondary outcome [1]
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Change in lipid profile.
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Assessment method [1]
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Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (mmol/L) measured by immunoassay in a fasted state.
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Timepoint [1]
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Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (mmol/L) will be assessed at baseline, and 6-months post commencement of treatment.
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Secondary outcome [2]
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Change in weight (BMI).
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Assessment method [2]
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Kilograms (kg/m^2) assessed using a seca digital scale (weight) also capable of measuring height (electronic stadiometer)
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Timepoint [2]
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Weight and BMI will be assessed at baseline, and a 3- and 6-months post commencement of treatment.
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Secondary outcome [3]
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Change in thyroid autoimmunity.
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Assessment method [3]
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Thyroid peroxidase antibody titre measure by immunoassay
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Timepoint [3]
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Thyroid peroxidase antibody titre will be assessed at baseline, and a 3- and 6-months post commencement of treatment.
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Eligibility
Key inclusion criteria
- Age greater of equal to 18-years.
- Greater than 3 months since diagnosis of Hashimoto’s disease.
- Stable thyroxine dose for greater or equal to 3 months.
- Thyroid stimulating hormone (TSH) level within normal range.
- Dissatisfaction with thyroxine treatment.
- Patient-perceived residual hypothyroid symptoms.
- Ability to provide written informed consent and adhere to the study protocol.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Documented allergy to naltrexone.
- Opioid dependence or inability to abstain from opioids during the study.
- Thyroid hormone replacement with anything other than thyroxine monotherapy.
- Recent modification (within 3-months) of diet, lifestyle or medication known to impact weight, blood pressure, thyroid function or other important study outcome measures.
- Pregnancy or planning pregnancy.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Via sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Yes, unstratified simple randomisation using a randomisation table from a statistic book
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/06/2025
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Actual
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Date of last participant enrolment
Anticipated
1/12/2026
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Actual
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Date of last data collection
Anticipated
1/06/2027
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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RACP ESA Research Establishment Fellowship
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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St. Vincent's Clinic Foundation
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Address [2]
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Country [2]
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Australia
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Primary sponsor type
Hospital
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Name
St. Vincent's Hospital, Sydney
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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St Vincent’s Hospital Human Research Ethics Committee
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Ethics committee address [1]
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https://svhs.org.au/home/research-education/research-office
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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04/11/2023
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Approval date [1]
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31/01/2024
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Ethics approval number [1]
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2023/ETH02549
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Summary
Brief summary
Many people with hypothyroidism do not feel well, even when their blood tests say their thyroid levels are normal. Apart from thyroxine, there are no other approved medications available to treat hypothyroidism. Naltrexone, a medication typically used to treat other conditions, may help people with hypothyroidism feel better when taken at a low dose. The purpose of this study is to determine whether naltrexone is beneficial when used in addition to thyroxine for the treatment of hypothyroidism. Our proposed study will test if naltrexone improves quality of life and other health related measures versus a placebo tablet. This will help us to understand whether this medication (naltrexone) should be studied further as a potential treatment for hypothyroidism. Medications must be approved for use by the Australian Federal Government. Naltrexone is currently approved in Australia to treat alcohol and opioid dependence. However, it is not approved to treat hypothyroidism. Therefore, it is an experimental medication for treatment of hypothyroidism secondary to Hashimoto’s thyroiditis. This means that it must be tested to see if it is effective for this indication.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Christopher Alan Muir
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Address
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Department of Endocrinology, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW 2010
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Country
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Australia
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Phone
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+61 4 5013 3265
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Christopher Alan Muir
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Address
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Department of Endocrinology, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW 2010
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Country
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Australia
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Phone
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+61 2 8382 2622
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Christopher Alan Muir
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Address
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Department of Endocrinology, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW 2010
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Country
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Australia
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Phone
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+61 2 8382 2622
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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